Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo. A Randomized Double Blind Placebo Controlled Monocentric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluation Vitiligo
研究概览
简要总结
The role of the oxidative stress in vitiligo is supported by many studies but robust data are lacking concerning their interest as therapeutic agents. The objective of the study is to compare the association of GLISODIN (a gastro-protected superoxide dismutase) and Nb-UVB to Nb-UVB and placebo for treating vitiligo.
Adult patients with non-segmental vitiligo affecting more than 5% of body surface area will be included.
The main criteria of evaluation will be the VES score at 6 months compared to baseline in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vitiligo, SOD, UVB
- •Non-segmental vitiligo with BSA>5%
排除标准
- •Criteria of non-inclusion
- •Segmental or mixed vitiligo
- •Pregnancy
- •Vitiligo lesions localized only on hands and feet
- •Immuno-suppressive drugs
- •Corticosteroids
- •Photosensitive drugs
- •Photodermatosis
- •Personal history of skin cancer
- •Allergy to gluten
研究组 & 干预措施
Drug
4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
干预措施: Glisodin tablet (Drug)
Placebo
4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Evaluation Vitiligo
时间窗: At Baseline and at 6 weeks
Change from Baseline VES (Vitiligo Extend Score) at 6 months
次要结局
- Quality of life of patient(At Baseline and at 6 weeks)